The following article features coverage from the American Society of Clinical Oncology 2020 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.

Donafenib, a novel multikinase inhibitor, may be superior to sorafenib as first-line therapy for advanced hepatocellular carcinoma (HCC), findings presented at the ASCO20 Virtual Scientific Program suggest.

In a phase 2/3 open-label trial, Feng Bi, MD, PhD, of the West China Hospital, Sichuan University, and collaborators randomly assigned 668 patients with unresectable or metastatic HCC to receive either donafenib (334 patients) or sorafenib (334 patients), the current standard first-line therapy. The primary end point of the trial was overall survival (OS).

In an efficacy analysis based primarily on a full analysis set (659 patients), donafenib was significantly associated with a longer median overall survival (OS) compared with sorafenib (12.1 vs 10.3 months) and a nearly 17% decreased risk of death (95% CI, 0.699-0.988, P =.0363), Dr Bi and colleagues reported. Donafenib also was significantly associated with better median OS in an analysis of all 668 patients in the intent-to-treat population (12.0 vs 10.1 months) and an approximately 16% decreased risk of death (95% CI, 0.706-0.996, P =.0446).

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The investigators observed no significant differences in median progression-free survival (3.7 vs 3.6 months, P =.2824), objective response rate (4.6% vs 2.7%, P =.2448), and disease control rate (30.8% vs 28.7%, P =.5532).

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Grade 3 or higher adverse events (AEs) occurred significantly less frequently in the donafenib arm compared with the sorafenib arm (57.4% vs 67.5%, P =.0082). AEs leading to treatment interruption also occurred significantly less frequently in the donafenib arm (30.3% vs 42.5%, P =.0013).

Common AEs with donafenib included hand-foot skin reaction (50.5%), aspartate aminotransferase increase (40.5%), blood bilirubin increase (39.0%), platelet count decrease (37.8%), and diarrhea (36.6%), according to the investigators.

“Donafenib significantly improves OS over sorafenib with favourable safety and tolerability,” the investigators concluded in their study abstract. “Donafenib is a promising superior first-line therapy for advanced HCC.”

Read more of Cancer Therapy Advisor‘s coverage of the ASCO 2021 meeting by visiting the conference page.


Bi F, Qin S, Gu S, et al. Donafenib versus sorafenib as first-line therapy in advanced hepatocellular carcinoma: An open-label, randomized, multicenter phase II/III trial. Presented at: ASCO20 Virtual Scientific Program. J Clin Oncol. 2020;38(suppl):abstr 4506.